JAMA Neurology: After stroke, is fluoxetine effective in alleviating depression symptoms?

In the first year after a stroke, one in three people is affected by depression

Fluoxetine hydrochloride is a widely used selective serotonin reuptake inhibitor, which is more effective than placebo in the treatment of depression in adults.

The FLAME trial randomly assigned 118 adults with recent strokes to receive 20 mg of fluoxetine or placebo daily for 3 months

A systematic review summarized the results of 6 small studies investigating the effect of fluoxetine on the mood of stroke patients, but only 2 studies were placebo-controlled

After 3 months, there was no difference in the scores of the Hamilton Depression Rating Scale between the treatment groups

Recently, 3 large randomized, double-blind, placebo-controlled clinical trials studied the effects of fluoxetine on stroke patients, in which depression was recorded as a secondary outcome

Fluoxetine did not improve the functional outcome, but FOCUS and EFFECTS found that fluoxetine reduced the incidence of depression

Osvaldo P.

The main clinical question: To study whether the use of 20 mg of fluoxetine hydrochloride per day can reduce the proportion of people who have clinically significant depressive symptoms after stroke

Intervention measures

Through the Patient Health Questionnaire (PHQ-9), a score of 9 or lower is a pre-specified secondary result in the trial

They found that a total of 607 participants (378 men [62.

At baseline, 112 patients (18.

During the follow-up period, 126 (21.

During the trial period, among participants with a PHQ-9 score below 9 at baseline, the ratio of fluoxetine hydrochloride to placebo was similar, with a PHQ-9 score of 9 or higher
.

Compared with the fluoxetine group, the number of clinicians diagnosed with depression was slightly higher in the placebo group than in the fluoxetine group (42 out of 602 [7.
0%], 26 out of 601 [4.
3%]; P=.
05)
.

By week 26, 14 participants (2.
3%) in the placebo group and 12 participants (1.
9%) in the fluoxetine group had died (P = .
67)
.

The important significance of this RCT study is that it found that compared with placebo, conventional treatment with 20 mg of fluoxetine per day did not reduce the proportion of people with clinically significant depressive symptoms after stroke, nor did it affect the prescribing or acceptance of antidepressants.
Proportion of non-medicated people
.

Original source:

Almeida OP, Hankey GJ, Ford A, et al.
Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery: The AFFINITY Randomized Clinical Trial .
JAMA Neurol.
Published online August 2, 2021.
doi:10.
1001/jamaneurol.
2021.
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